MedPath

Diprivan

Diprivan® (Propofol) Injectable Emulsion, USP

Approved
Approval ID

ee0c3437-614d-4631-a061-257f5f60c70b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 28, 2023

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

PROPOFOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-269
Application NumberNDA019627
Product Classification
M
Marketing Category
C73594
G
Generic Name
PROPOFOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 24, 2023
FDA Product Classification

INGREDIENTS (6)

SOYBEAN OILInactive
Quantity: 100 mg in 1 mL
Code: 241ATL177A
Classification: IACT
PROPOFOLActive
Quantity: 10 mg in 1 mL
Code: YI7VU623SF
Classification: ACTIB
EGG PHOSPHOLIPIDSInactive
Quantity: 12 mg in 1 mL
Code: 1Z74184RGV
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
GLYCERINInactive
Quantity: 22.5 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Diprivan - FDA Drug Approval Details